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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Express Scripts

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205917

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NDA 205917 describes PARICALCITOL, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Bionpharma Inc, Dr Reddys Labs Ltd, Eci Pharms Llc, Marksans Pharma, Rising Pharms Inc, Teva Pharms Usa, Accord Hlthcare, Akorn, Amneal Pharms Co, Hikma Pharms, Hospira Inc, Mylan Labs Ltd, and Sandoz Inc, and is included in sixteen NDAs. It is available from seventeen suppliers. Additional details are available on the PARICALCITOL profile page.

The generic ingredient in PARICALCITOL is paricalcitol. There are ten drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.
Summary for 205917
Applicant:Hikma Pharms
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205917
Suppliers and Packaging for NDA: 205917
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 205917 NDA West-Ward Pharmaceutical Corp 0143-9596 0143-9596-25 25 VIAL, MULTI-DOSE in 1 CARTON (0143-9596-25) > 2 mL in 1 VIAL, MULTI-DOSE (0143-9596-01)
PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 205917 NDA West-Ward Pharmaceutical Corp 0143-9624 0143-9624-25 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9624-25) > 1 mL in 1 VIAL, SINGLE-DOSE (0143-9624-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.002MG/ML (0.002MG/ML)
Approval Date:Nov 18, 2014TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.005MG/ML (0.005MG/ML)
Approval Date:Nov 18, 2014TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.01MG/2ML (0.005MG/ML)
Approval Date:Nov 18, 2014TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Harvard Business School
Express Scripts

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